The Management of Clinically Localized Prostate Cancer National Institutes of Health Consensus Development Conference Statement June 15-17, 1987 This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/. This statement was originally published as: The Management of Clinically Localized Prostate Cancer. NIH Consens Statement 1987 Jun 15-17;6(10):1-6 For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: The Management of Clinically Localized Prostate Cancer. NIH Consens Statement Online 1987 Jun 15-17 [cited year month day];6(10):1-6. Introduction Prostate cancer is the second most common form of malignant disease in American men. It is one of the most common cancers in men over the age of 50, with the incidence increasing each decade after the age of 50. Approximately 96,000 new cases of prostate cancer will be diagnosed in 1987, of which 50,000 are clinically localized, according to the American College of Surgeons, and there are approximately 26,000 deaths from prostate cancer annually. It is a common finding at autopsy in men over the age of 50 years. The most common histologic tumor type is adenocarcinoma. The etiology remains unknown at the present time. Prostate cancer is discovered usually by rectal examination performed during a physical examination or detected incidentally in the histologic material obtained from a transurethral prostatectomy being performed for enlargement of the prostate. Patients with localized disease may be asymptomatic at the time of the diagnosis of prostate cancer or may have symptoms of urinary retention. The extent of tumor involvement (stage) customarily is described by a classification system that has undergone evolution and modification over the years. Difficulties in describing disease extent have arisen from the use of different staging systems and from staging based on clinical as opposed to surgical findings. Because of this lack of uniformity in the staging systems, the analysis of data remains complex and difficult. Two accepted clinical staging systems are in use. The American Urologic System consists of A, B, C, and D stages, and the American Joint Committee uses the T, N, and M system. Radical prostatectomy has a long history as the definitive management for localized prostate cancer. The retropubic approach, which readily permits staging lymphadenectomy, has become more common than the perineal approach. Recently, the surgical technique has been refined to preserve the nerves essential for potency. Radiation therapy is another form of definitive treatment and is usually given by means of high-energy external beam photons using linear accelerators. Hormone therapy is an effective means of palliation whose role in the management of early disease is under renewed investigation as an adjuvant to definitive therapy of the primary tumor. Chemotherapy generally has been used in the palliation of patients with advanced hormone refractory disease. After the completion of treatment of prostate cancer, the followup of the patient includes physical examination, laboratory studies, and imaging examinations. The exact combination of laboratory studies and imaging examinations has not been agreed upon, and this situation is undergoing evolution in the United States. The natural history of this disease is variable, and some untreated patients may die without symptoms of prostate cancer. Competing (noncancer) causes of death are common in the age group affected by prostate cancer. These factors make the significance of therapeutic intervention more difficult to assess than in other cancers. The general quality of life and sexual functioning can be affected by treatment for prostate cancer. These aspects should be considered when the physician helps the patient to choose the best course of treatment. To evaluate new information and resolve issues regarding optimal treatment, the National Cancer Institute and the Office of Medical Applications of Research of the National Institutes of Health convened a Consensus Development Conference on the Management of Clinically Localized Prostate Cancer on June 15-17, 1987. After a day and a half of presentations by experts and discussion by the audience, a consensus panel drawn from specialists and generalists from the medical profession and related scientific disciplines, clinical investigators, and public representatives considered the evidence. The panel agreed on answers to the following key questions: What is the utility of pathological assessment and imaging techniques in the staging of prostate cancer? When is pelvic node dissection necessary? Who is the optimal candidate for radical prostatectomy? What is the morbidity of the procedure, and how can it be minimized with preservation of curative potential? Who are the candidates for definitive radiation therapy? What methods are optimal, and what are the long-term results in terms of local control and survival? What is the morbidity of the procedures, and how can it be minimized with preservation of curative potential? Should definitive radiation therapy, hormone therapy, and/or chemotherapy be employed as adjuvant treatment in high-risk patients? What directions for future research are indicated? What Is the Utility of Pathological Assessment and Imaging Techniques in the Staging of Prostate Cancer? When Is Pelvic Node Dissection Necessary? An accurate histologic or cytologic diagnosis of cancer of the prostate is essential prior to the planning of treatment. The histologic diagnosis usually is established from a specimen obtained by core biopsy or transurethral resection. It may be obtained cytologically from a fine needle aspiration. Histologic and/or cytologic grading and staging (extent of disease) are necessary to plan appropriate treatment and provide a prognosis. There are several systems for grading prostate cancer that yield similar information and are all based upon the degree of tumor differentiation and growth patterns. The Gleason histologic grading system is based on five tumor patterns. The values of the predominant and the lesser patterns are added together to generate a numerical histologic score. Histologic grading correlates well with the biological degree of malignancy, i.e., tumor invasion, metastatic spread, and mortality rate. The nature of the specimen obtained by fine needle aspiration usually precludes histologic but not cytologic grading based on nuclear anaplasia. Experienced observers find that cytologic grading yields results and information similar to histologic grading, but this requires further prospective correlation. The simplicity of fine needle aspiration should increase its use. All tissue sampling techniques have a recognized risk of error. Flow cytometry can be used to measure DNA content. Abnormal DNA content appears to be predictive of more aggressive biological behavior. Additional study is required to determine its prognostic utility in routine practice. Pelvic lymphadenectomy is a surgical staging procedure employed when clinical decisions depend on accurate knowledge of the presence or absence of metastatic tumor in the pelvic lymph nodes. It is performed most commonly prior to a planned radical prostatectomy. Pelvic lymph node dissection continues to provide staging information that can be obtained by no other method. Biochemical evaluation is critical to the initial staging assessment. Serum alkaline phosphatase and acid phosphatase determinations are helpful in identifying patients with metastatic disease. The serum prostate-specific antigen (PSA) is elevated more frequently in men with prostate cancer than is the acid phosphatase. PSA can be used to monitor response to both local and systemic therapies. PSA is specific for prostate tissue but not for prostate cancer, precluding its use in screening. Anatomic imaging contributes to the staging assessment of patients presenting with prostate carcinoma. The initial evaluation requires isotopic bone scan, chest roentgenogram, and an imaging evaluation of the upper urinary tract. While lymphography has been used in the past, its current applications are limited. More locally directed imaging techniques for clinical staging include transrectal ultrasound, computerized tomography, and magnetic resonance imaging. It is essential that results of all imaging examinations be carefully correlated with results of digital rectal examination, cystoendoscopy, and pertinent laboratory tests in the determination of the clinical stage of the cancer. Imaging equipment should be state of the art. There is no single best procedure, and all procedures have significant limitations in their accuracy. The value of transrectal ultrasound is operator-dependent. It should employ a dual modality intrarectal probe. Intraprostatic anatomy, capsular integrity, and the seminal vesicles can be imaged. Pelvic adenopathy cannot be demonstrated. Computerized tomography can assess the periprostatic area and lymph Node size. Intraprostatic detail is poor, and masses rarely are identified. The detection of enlarged lymph nodes is highly sensitive, but normal-sized nodes may contain microscopic tumor. Magnetic resonance imaging, like transrectal ultrasound, can demonstrate intraprostatic anatomy. The technique appears to be as accurate as computerized tomography and transrectal ultrasound in the detection of periprostatic extension and seminal vesicle involvement. It is competitive with computerized tomography in demonstrating pelvic adenopathy. At present, scientific controlled studies are lacking in adequate patient numbers to permit other than a gross comparison of imaging methods. Clinical comparisons are biased by patient selection and nonblinded observer factors.   Who Is the Optimal Candidate for Radical Prostatectomy? What Is the Morbidity of the Procedure, and How Can It Be Minimized With Preservation of Curative Potential? A radical prostatectomy includes the removal of the entire prostate and seminal vesicles with adequate resection margins by either a retropubic or perineal approach. The adequacy of surgical margins should be confirmed by a thorough pathological evaluation. An appropriate candidate for definitive primary radical prostatectomy has a tumor that is localized to the prostate (A2, B1, B2). The patient should be an acceptable surgical candidate and have no significant comorbid disease. Patients should have completed a negative staging evaluation for distant metastases. Ideally, pelvic lymphadenectomy should be performed with a retropubic prostatectomy and for high-risk patients having a perineal prostatectomy. Adequate staging information will be obtained with a "limited node dissection" that includes nodes within the boundaries of the external and internal iliac vessels and obturator fossa. This will minimize complications of lymphedema and lymphocele. Radical prostatectomy is associated with both perioperative morbidity and late side effects. These complications can include urinary incontinence, urethral stricture, impotence, and morbidity associated with anesthesia and a major surgical procedure. Significant incontinence and stricture are uncommon. The incidence of impotence can be reduced with newer surgical techniques using an anatomical dissection that preserves nerves necessary for erection. The preservation of potency with this technique is achieved in a majority of patients, although it is related to tumor size and patient age. Attempts to preserve potency must not compromise adequate removal of the tumor. Clinically evident local recurrence following radical prostatectomy is not common. Cancer-free survival rates at 15 years for patients with cancer limited to one lobe of the prostate approach the expected survival of men in the general population in a comparable age group. Disease-free survival rates are less with larger tumors.   Who Are the Candidates for Definitive Radiation Therapy? What Methods Are Optimal and What Are the Long-Term Results in Terms of Local Control and Survival? What Is the Morbidity of the Procedures, and How Can It Be Minimized With Preservation of Curative Potential? Candidates for definitive radiation therapy must have a confirmed pathological diagnosis of cancer that is clinically confined to the prostate and/or surrounding tissues (A2, B, C). Patients should have completed a negative staging evaluation for distant metastases. An effective radiation therapy regimen should deliver a homogeneous dose to the entire tumor volume. Such a dose is delivered most commonly by external beam radiation therapy. In selected instances, interstitial irradiation can be delivered with or without external beam radiation therapy when the disease is confined to the prostate gland. Although lower local control rates have been reported with interstitial therapy, efforts are being made to improve these results by careful attention to technique and dosimetry. Newer radiation modalities such as particle therapy are under active investigation. Local tumor in the prostatic and periprostatic tissue can be controlled effectively by irradiation. However, the impact on overall survival of treating the regional lymph nodes is unclear. Definitive radiation therapy is associated with both acute and chronic effects on normal tissue, including proctitis, enteritis, and cystitis. These are generally acceptable and reversible but may be chronic and rarely sufficiently severe to require corrective surgical intervention. Other complications include occasional urethral stricture formation in patients who have undergone a previous transurethral resection of the prostate. Potency is preserved with definitive radiation therapy in the majority of patients but may diminish over time. Morbidity can be minimized by the use of sophisticated radiation techniques, including the use of linear accelerators producing high energy x-ray beams, and careful treatment planning, including simulation and individualized shielding. The assessment of local control is critical in evaluating the results of radiation therapy. Reported rates of local tumor control are a function of the diagnostic method used to establish them. By clinical criteria alone, the local control rates are higher than if postradiation positive biopsies are used as the end point. The likelihood of finding histologically positive biopsies following radiation therapy is of concern and related to the clinical disease stage. The significance of this currently is being studied, but it may be predictive of subsequent distant relapse. Survival is related to the initial clinical stage and histologic grade. The 10-year crude survival rates of patients with low stage disease (A2, B) treated with radiation therapy are equivalent to the expected survival of men in the comparable age groups. Survival rates in more locally advanced stages of disease clearly reflect the increased incidence of cancer death.   Should Definitive Radiation Therapy, Hormone Therapy, and/or Chemotherapy Be Employed as Adjuvant Treatment in High-Risk Patients? No data are available to support the routine use of adjuvant therapy after definitive surgery or irradiation. Preliminary data suggest that adjuvant hormone manipulation and irradiation deserve further study in locally advanced prostate cancer patients. A definition of the appropriate patient population for such studies remains to be developed.   What Directions for Future Research Are Indicated? The Consensus Development Conference on the Management of Clinically Localized Prostate Cancer provided a large body of information to optimize the diagnosis, staging, and management of this prevalent disease. While many controversies were addressed, numerous questions were identified that await answers and thus serve as the focus for future research directions. These issues will require the collaborative input of investigators from both clinical and basic disciplines. As outlined in the consensus statement, many questions are being answered currently--others will be the focus for future research. Directions for Clinical Research Agree to a uniform classification and schema for histologic and cytologic grading, disease staging, and response criteria that are acceptable to health care professionals caring for patients with prostate cancer. Define the appropriate use of diagnostic imaging in staging prostate cancer patients through well-designed, controlled comparison studies. The development of imaging methods to measure tumor volume could provide a noninvasive predictor of the aggressiveness of cancer. Encourage educational programs for pathologists and cytologists in the diagnosis of prostate cancer with the purpose of increasing accuracy and uniformity. Assess the availability and quality of surgical treatment and initiate surgical educational programs as needed. Accept a uniform method for data reporting and statistical analyses that will allow meaningful comparisons of treatment results reported by various disciplines. Identify clinical and pathological prognostic variables. The identification of "low and high risk" features may allow more appropriate selection of treatments for patients with clinically localized disease. Parameters to study may include morphologic predictors, the correlation of DNA flow cytometry, prostate-specific antigen determination, and tumor cytogenetics with disease outcome. Assess the clinical significance of positive postradiation biopsies, and identify ways to reduce the incidence of these positive biopsies. Assess in controlled trials the role of localized postoperative irradiation in patients with positive margins after radical prostatectomy. Assess in controlled trials the role of adjuvant hormonal therapy in patients with locally advanced disease after radical prostatectomy and/or definitive radiation therapy. Clarify the clinical significance and therapeutic implications of the extent of nodal involvement. Address the influence of treatment programs on the quality of life of patients and their loved ones. Identify appropriate psychosocial and psychosexual instruments and end points to assess quantitatively the effect of treatment in patients with both localized and metastatic disease. Study and implement innovative interventions to improve the psychological outcome. Agree upon a uniform clinical and pathological definition of stage A1 prostate cancer. Initiate studies to define the natural history of untreated stage A1 patients to help determine which patients may benefit from treatment.   Directions for Basic Research Encourage basic research to elucidate fundamental processes regulating normal prostate and prostate cancer growth and their impact on the natural history of disease. Assess the diagnostic and therapeutic role of prostate-cancer-specific monoclonal antibodies.  Conclusion Radical prostatectomy and radiation therapy are clearly effective forms of treatment in the attempt to cure tumors limited to the prostate for appropriately selected patients. Comparisons across studies suggest comparable 10-year survival rates with either form of management. What remains unclear is the relative merit of each in producing lifelong freedom from cancer recurrence. It is known that traditional radical prostatectomy can provide 15-year cancer-free survival, in appropriately selected patients, equivalent to that of a comparably aged control population. On the other hand, sufficient long-term followup does not yet exist to permit a conclusion about the ability of radiation therapy to eradicate such cancer in an equivalent proportion of patients. After appropriate primary irradiation, the long-term complication rate is now well defined and appears acceptable. The new approach to prostatectomy is clearly associated with a reduction in postoperative impotence. The true comparative incidence of impotence over time, however, awaits prospective evaluation. While impotence may result from the alteration of normal anatomy, the psychological considerations should not be overlooked. Sexual rehabilitation should address both medical and psychological needs. Information that a patient should have available when considering with his physician the choice of treatment includes: Probability of cure, mortality, complications, and other side effects of radical prostatectomy and radiation therapy. Risk of impotence and incontinence for either treatment. Psychosocial consequences of either choice. Extent and risk of pretreatment staging assessment tests. Economic consequences of each form of treatment.   As competing, noncancer-related causes of death (e.g., cardiovascular disease) may be expected to decrease for men over the age of 50, the issue of cure will become more important in low stage disease. Properly designed and completed randomized trials that evaluate both disease control and quality of life after modern radiation therapy compared with radical prostatectomy are essential.   Consensus Development Panel Robert B. Livingston, M.D. Conference and Panel Chairperson Professor of Medicine Head Division of Oncology University of Washington Seattle, Washington Alfred A. Bartolucci, Ph.D. Professor and Chairman Department of Biostatistics and Biomathematics University of Alabama at Birmingham Birmingham, Alabama Joshua A. Becker, M.D. Professor and Chairman Department of Radiology State University of New York Health Science Center at Brooklyn Brooklyn, New York William C. DeWolf, M.D. Associate Professor of Surgery Harvard Medical School Beth Israel Hospital Boston, Massachusetts John T. Ellis, M.D. Chairman and Professor Department of Pathology The New York Hospital-Cornell Medical Center New York, New York H. Anthony Engelbrecht, M.D. Director Department of Radiation Oncology Merritt Peralta Medical Center Associate Clinical Professor of Radiology Stanford Medical School President California Radiation Therapy Association Oakland, California Marc B. Garnick, M.D. Associate Professor of Medicine Harvard Medical School Dana-Farber Cancer Institute Boston, Massachusetts John T. Grayhack, M.D. Herman L. Kretschmer Professor and Chairman Department of Urology Northwestern University Medical School Chicago, Illinois Lance K. Heilbrun, Ph.D. Director of Biostatistics Division of Medical Oncology Wayne State University Detroit, Michigan James G. Jones, M.D. Professor and Chairman Department of Family Medicine East Carolina University School of Medicine Greenville, North Carolina Shannon B. McGowan, M.A. Psychotherapist/Oncology Consultant Private Practice Point Richmond, California John Muir Community Hospital and Cancer Center Walnut Creek, California C. Kent Osborne, M.D. Professor of Medicine University of Texas Health Science Center San Antonio, Texas Joel E. Tepper, M.D. Associate Professor of Radiation Therapy Harvard Medical School Radiation Therapist Massachusetts General Hospital Boston, Massachusetts John R. Thornbury, M.D. Professor of Radiology Department of Radiology University of Rochester Medical Center Rochester, New York Speakers Malcolm A. Bagshaw, M.D. "Status of the Radiation Treatment of Prostatic Cancer at Stanford" Professor and Chairman Department of Therapeutic Radiology Stanford University School of Medicine Stanford, California Mitchell C. Benson, M.D. "Value of Fine Needle Aspiration and Flow Cytometry in the Diagnosis and Evaluation of Prostate Cancer" Assistant Professor of Urology Columbia-Presbyterian Medical Center New York, New York David P. Byar, M.D. "Hormone Therapy: Results of the VACURG Studies" Chief Biometry Branch National Cancer Institute National Institutes of Health Bethesda, Maryland Ronald A. Castellino, M.D. "Lymphography in Initial Staging of Clinically Localized Prostate Cancer" Professor and Chairman (Acting) Department of Diagnostic Radiology and Nuclear Medicine Stanford University Medical Center Stanford, California Albert B. Einstein, Jr., M.D. "Adjuvant Hormonal Therapy for Locally Advanced Prostate Cancer" Medical Oncologist Virginia Mason Medical Center Seattle, Washington Mario A. Eisenberger, M.D. "Chemotherapy for Prostatic Carcinoma" Assistant Professor of Medicine and Oncology University of Maryland Cancer Center Baltimore, Maryland Fuad S. Freiha, M.D., F.A.C.S. "Selection Criteria for Radical Prostatectomy Based on Morphometric Studies" Associate Professor and Chief Urologic Oncology Division of Urology Stanford University Medical Center Stanford, California Robert P. Gibbons, M.D. "Total Prostatectomy for Localized Prostatic Cancer--Long-Term Surgical Results and Current Morbidity: The Virginia Mason Clinic Experience" Head Section of Urology and Renal Transplantation Virginia Mason Clinic Seattle, Washington Donald F. Gleason, M.D., Ph.D. "Histologic Grading and Clinical Staging of Prostatic Cancer" Pathologist Minneapolis, Minnesota Thomas W. Griffin, M.D. "Fast Neutron Radiotherapy for Advanced Prostate Cancer" Professor and Chairman Department of Radiation Oncology University of Washington Hospital Seattle, Washington Gerald E. Hanks, M.D. "National Practice Results of External Beam Radiation for Prostate Cancer" Professor of Radiation Therapy University of Pennsylvania and Fox Chase Cancer Center Philadelphia, Pennsylvania Hedvig Hricak, M.D. "Noninvasive Imaging for Staging Prostate Cancer: MRI, CT, and Ultrasound" Professor of Radiology and Urology Department of Radiology University of California School of Medicine San Francisco, California Paul H. Lange, M.D. "Adjuvant Postoperative Radiation Therapy Following Radical Postatectomy" Professor of Urologic Surgery Vice Chairman Department of Urologic Surgery University of Minnesota Health Sciences Center Mayo Memorial Building Minneapolis, Minnesota Herbert Lepor, M.D. "Cause-Specific Survival Analysis Following Radical Prostatectomy: The Johns Hopkins Experience" Assistant Professor of Surgery (Urology) Jewish Hospital of St. Louis at Washington University Medical Center St. Louis, Missouri Richard G. Middleton, M.D. "Value of and Indications for Staging Pelvic Lymph Node Dissection" Professor of Surgery and Chairman Division of Urology University of Utah Medical Center Salt Lake City, Utah David F. Paulson, M.D. "Randomized Series of Surgery Versus Radiation Therapy" Professor and Chief of Urology Duke University Medical Center Durham, North Carolina Carlos A. Perez, M.D. "Definitive Radiation Therapy in the Primary Treatment of Carcinoma of the Prostate: The MIR Experience" Professor of Radiology Director Radiation Oncology Center Mallinckrodt Institute of Radiology Washington University School of Medicine St. Louis, Missouri Miljenko V. Pilepich, M.D. "Radiation Therapy: RTOG Data" Associate Professor of Radiation Oncology Washington University School of Medicine St. Louis, Missouri Peter T. Scardino, M.D. "Local Control of Prostate Cancer With Radiation Therapy: Frequency and Significance of Positive Postirradiation Prostatic Biopsy Results" Professor of Urology Baylor College of Medicine Houston, Texas William U. Shipley, M.D. "Radiation Therapy of Men with Localized Prostatic Carcinoma: The Massachusetts General Hospital Experience" Associate Professor of Radiation Therapy Harvard Medical School Associate Director Massachusetts General Hospital Cancer Center Department of Radiation Medicine Boston, Massachusetts Patrick C. Walsh, M.D. "Radical Prostatectomy with Preservation of Sexual Function" David Hall McConnell Professor Director Department of Urology Johns Hopkins University School of Medicine Johns Hopkins Hospital Baltimore, Maryland Willet F. Whitmore, Jr., M.D. "Overview: Historical and Contemporary" "Interstitial Irradiation with 125I" Attending Surgeon Urology Service Memorial Sloan-Kettering Cancer Center Professor of Surgery (Urology) The New York Hospital-Cornell Medical Center New York, New York Horst Zincke, M.D. "Radical Prostatectomy for High Stage (T3, N0/+M0) Prostate Cancer: The Need for Adjuvant Treatment" Professor Mayo Medical School Consultant Departments of Urology and Surgery Mayo Clinic Rochester, Minnesota Planning Committee John E. Antoine, M.D. Planning Committee Chairperson Associate Director Radiation Research Program Division of Cancer Treatment National Cancer Institute National Institutes of Health Bethesda, Maryland Michael J. Bernstein Director of Communications Office of Medical Applications of Research National Institutes of Health Bethesda, Maryland Andrew Chiarodo, Ph.D. Chief Organ Systems Program National Cancer Institute National Institutes of Health Bethesda, Maryland Joyce Doherty Information Specialist Officer of Cancer Communications National Cancer Institute National Institutes of Health Bethesda, Maryland Jerry M. Elliott Program Analyst Office of Medical Applications of Research National Institutes of Health Bethesda, Maryland Michael A. Friedman, M.D. Chief Clinical Investigations Branch Cancer Therapy Evaluation Program National Cancer Institute National Institutes of Health Bethesda, Maryland Eli Glatstein, M.D. Chief Radiation Oncology Branch Division of Cancer Treatment National Cancer Institute National Institutes of Health Bethesda, Maryland Robert B. Livingston, M.D. Conference and Panel Chairperson Professor of Medicine Head Division of Oncology University of Washington Seattle, Washington Elliott H. Stonehill, Ph.D. Assistant Director National Cancer Institute National Institutes of Health Bethesda, Maryland Patrick C. Walsh, M.D. David Hall McConnell Professor Director Department of Urology Johns Hopkins University School of Medicine Johns Hopkins Hospital Baltimore, Maryland Willet F. Whitmore, Jr., M.D. Attending Surgeon Urology Service Memorial Sloan-Kettering Cancer Center Professor of Surgery (Urology) The New York Hospital--Cornell Medical Center New York, New York Richard D. Williams, M.D. Professor and Chairman Department of Urology University of Iowa Hospitals and Clinics Iowa City, Iowa Conference Sponsors National Cancer Institute Vincent T. DeVita, Jr., M.D. Director Office of Medical Applications of Research National Institutes of Health Itzhak Jacoby, Ph.D. Acting Director

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